Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00134940
Status:
COMPLETED
Last Update Posted:
2011-06-16
First Post:
2005-08-23
Brief Title:
Post-marketing Study to Collect Safety Data in Heart Transplant Patients Receiving Everolimus
Sponsor:
Novartis
Organization:
Novartis
Study Overview
Official Title:
A Non-interventional Protocol to Collect Prospective and Retrospective Data in Patients Receiving Everolimus to Prevent Acute Rejection Following Cardiac Transplantation
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this observational protocol is to evaluate the use of everolimus in routine clinical practice for heart transplants
Primary outcome measures incidence of acute rejection episodes Secondary outcomes safety
Primary outcome measures incidence of acute rejection episodes Secondary outcomes safety
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None